UMIN-CTR Clinical Trial

Basic information
Public title	Effects of medical equipments that improve physical functions on psychological states
Acronym	Effects of medical equipments that improve physical functions on psychological states
Scientific Title	Effects of medical equipments that improve physical functions on psychological states
Scientific Title:Acronym	Effects of medical equipments that improve physical functions on psychological states
Region	Japan

Condition
Condition	Depressive symptoms
Classification by specialty	Medicine in general Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In recent years, it is becoming apparent that various organs and cells exchanges information dynamically through several neurotransmitters in the body and this phenomenon supports physical and mental health conditions. In this study, we attempt to reveal the effects of medical equipments that improve physical functions on psychological states such as flow experiences, empathy, and stress coping abilities.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	After 10-minute physical stimulation using a low frequency therapy device or a dry hot pack device, we ask the participants to conduct psychological tasks that can evaluate flow experiences / empathy / stress coping abilities and quantitatively evaluate the influence of transient physical stimulations on flow experiences / empathy / stress coping abilities .
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Perform a 10-minute physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment(program 1).
Interventions/Control_2	Perform a 10-minute physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment (program 2).
Interventions/Control_3	Perform a 10-minute sham-physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Healty people
Key exclusion criteria	Those who fall under the following which are thought to have a large electric influence compared with the intended effect are excluded. 1.people using psychotropic drugs and drugs that affect the mental state 2. people with sensory disorders such as dull warmth 3. pregnant women 4. people with malignant tumors and heart disease 5. people with skin irritation, injury or lesions 6. people who have a febrile disease, acute inflammation, and purulent disease 7. people who have a possibility of blood flow disorder 8. people who suffer from deep thrombophlebitis 9. people who judged that the doctor is inappropriate
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Matsunaga
Organization	Aichi Medical University School of Medicine
Division name	Department of Health and Psychosocial Medicine
Zip code	4801195
Address	1-1 Yazakokarimata, Nagakute, Aichi
TEL	0561-62-3311
Email	matsunag@aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Matsunaga
Organization	Aichi Medical University School of Medicine
Division name	Department of Health and Psychosocial Medicine
Zip code	4801195
Address	1-1 Yazakokarimata, Nagakute, Aichi
TEL	0561-62-3311
Homepage URL
Email	matsunag@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research <KAKENHI>
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aichi Medical University
Address	1-1 Yazakokarimata, Nagakute, Aichi
Tel	0561623311
Email	sec2030@mail.aichi-med-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Suspended
Date of protocol fixation	2018 Year 05 Month 25 Day
Date of IRB	2018 Year 05 Month 07 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 13 Day
Last modified on	2019 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037581

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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